Actively Recruiting
Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
Led by Peking University · Updated on 2024-12-12
600
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Schizophrenia, major depressive disorder, and bipolar disorder are common and disabling mental health conditions that cause significant challenges for patients, families, and society. This research aims to develop a precision treatment model tailored to the Chinese Han population, combining pharmacogenomic testing, quantitative assessment-based treatment, and therapeutic drug monitoring. The goal is to improve treatment outcomes, safety, efficiency, and reduce costs for patients with these psychiatric disorders. Participants are randomly assigned to one of two groups. In the Guided group, treatment choices and dosages are adjusted based on pharmacogenomic test results received within 3 to 5 working days, with dose changes made within two weeks to reach stable dosing. Treatments include antipsychotic monotherapy for schizophrenia, antidepressants for major depressive disorder, and mood stabilizers such as lithium or valproic acid for bipolar disorder, with additional medications added if symptoms persist. The Unguided group receives standard symptom-based treatment without pharmacogenomic guidance during the 12-week observation, with test results shared only after the study ends. Participants undergo clinical assessments at 4, 8, and 12 weeks using scales like PANSS, HAMD, and YMRS to measure symptom changes. Additional evaluations include medication adherence, plasma drug levels, social performance, and safety monitoring at these timepoints and at 6 and 12 months. The study lasts 12 weeks with ongoing follow-up assessments to monitor treatment effects and safety, providing a comprehensive evaluation of this precision treatment approach.
CONDITIONS
Brief Title
Development and Application of Precision Treatment Strategies for Common Mental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of schizophrenia, major depressive disorder, or bipolar disorder confirmed by MINI interview using DSM-5 criteria
- Baseline symptom severity meeting specific scale thresholds: PANSS score 60 for schizophrenia, HAMD-17 score 17 for depression, YMRS score 13 for bipolar disorder
- Han ethnicity
- Education level of middle school or higher
- No language barriers and able to cooperate with assessments and treatment
- Informed consent provided by patient or guardian
You will not qualify if you...
- History or current diagnosis of organic mental disorders, schizoaffective disorder, intellectual disability, dementia, other cognitive disorders, alcohol or drug dependence, or personality disorders
- Severe suicidal tendencies or risk of harming others
- Severe or unstable physical illnesses
- Narrow-angle glaucoma
- History of epilepsy or seizures
- Pregnancy or breastfeeding, or planning pregnancy
- Participation in another clinical trial or inability to complete this trial
- Deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive pharmacogenomics-guided or standard medication treatment based on their diagnosis of schizophrenia, major depressive disorder, or bipolar disorder. Drug types and dosages may be adjusted according to symptoms and pharmacogenetic testing results.
Visits at Weeks 4, 8, and 12 for clinical assessments and treatment adjustments
Trial Site Locations
Total: 1 location
1
Peking University Sixth Hostipal
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
W
Weihua Yue
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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